Product code LZF— General Hospital

FDA has cleared 7 devices under product code LZF between 1988 and 2020, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20201 clearance
• 20171 clearance
• 20021 clearance
• 19961 clearance
• 19941 clearance
• 19931 clearance
• 19881 clearance

• Via Medical Corp.3 clearances
• Pemlab Corp.1 clearance
• Optiscan Biomedical Corporation1 clearance
• Optiscan Biomedical Corp.1 clearance
• Metracor Technologies, Inc.1 clearance

• K192785 — OptiScanner® 5000 Glucose Monitoring SystemOptiscan Biomedical Corporation·2020-02-05
• K162042 — OptiScanner 5000 Glucose Monitoring SystemOptiscan Biomedical Corp.·2017-10-16
• K011238 — RODA (REAL TIME OXYGEN DYNAMICS ANALYSIS) MONITORING SYSTEMMetracor Technologies, Inc.·2002-01-08
• K951739 — PUMP/BLOOD CHEMISTRY MONITORVia Medical Corp.·1996-02-28
• K922997 — VIA 1-01 INFUSION PUMP/BLOOD CHEM. SYST. -- MOD.Via Medical Corp.·1994-01-11
• K920438 — VIA 1-01 INFUSION PUMP BLOOD CHEMISTRY SYSTEMVia Medical Corp.·1993-10-22
• K882830 — INFUSION PUMPPemlab Corp.·1988-12-30